(71 days)
The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.
The Bard Lubricious Ureteral Stent is a polyurethane stent with a hydrophilic (lubricious) coating which is intended to aid in stent insertion/removal and which has the potential to enhance patient comfort while indwelling; the stent also incorporates a monofilament suture loop which aids in stent removal.
This is a 510(k) premarket notification for a medical device (Bard® InLay™ Lubricious Double Pigtail Ureteral Stent) seeking substantial equivalence to a predicate device, not an AI/ML software device. Therefore, many of the requested criteria related to AI/ML device evaluations (e.g., ground truth, reader studies, effect size) are not applicable.
However, I can extract information related to the device's technical characteristics and how its performance was assessed in relation to the predicate device.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are typically that the new device meets the same design, manufacturing, and performance specifications as the predicate device or relevant standards, and that any differences do not raise new questions of safety or effectiveness. The "reported device performance" demonstrates that these criteria are met.
| Acceptance Criterion (Implied/Standard for Ureteral Stents) | Reported Device Performance (Bard Lubricious Ureteral Stent) |
|---|---|
| Indications for Use (same as predicate) | Identical to predicate device: "The Bard Lubricious Ureteral Stent is indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as presence of stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with Extracorporeal Shock Wave Lithotripsy (ESWL). The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique." |
| Disposable | Yes |
| Sterile | Yes |
| Stent Base Material (Polyurethane) | Polyurethane |
| X-Ray Opaque | Yes |
| Coating (Hydrophilic polymer / lubricious) | Hydrophilic polymer (lubricious)* (Different formula, different supplier than predicate) |
| Fr. Sizes Available (e.g., 4.7, 6, 7, 8 Fr.) | 4.7**, 6, 7 and 8 Fr. (4.7 Fr. stent will have a taper on the kidney-end tip) |
| Double Pigtail Lengths (e.g., 14-30cm) | 14, 20-30cm* (16 and 18cm lengths deleted compared to predicate) |
| Multilength Lengths (22-32cm) | 22-32cm (one overall adjustable length) |
| Pigtail Geometry | 360° curvature + 45° overlap (both ends) - (Predicate had "J" curl with no overlap. This is a difference, but not stated as failing an acceptance criterion, rather a design change.) |
| Suture Loop (USP Medical Grade nylon monofilament) | Yes - USP Medical Grade black nylon monofilament; 3-0 (Predicate had dark blue nylon. Color change, but both biocompatible.) |
| Guidewire Interface | 4.7 Fr. = .035" diameter*; 6, 7, 8 Fr. = .038" diameter* (4.7 Fr. interfaces with larger diameter guidewire than predicate) |
| Stent Clamp | Yes |
| Push Catheter Color | Orange* (Predicate was green. Color change.) |
| Push Catheter Material (HDPE) | High Density Polyethylene (HDPE) |
| Push Catheter Radiopacity | Radiopaque marker band near distal end* (Predicate N/A. Added feature.) |
| Push Catheter Length | 4.7, 6, 7, 8 Fr. = 17.75"* (Lengths changed; OD on new push catheter same as stent.) |
| Compliance with Standards | "Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses performance and functional testing against standards and guidelines, rather than a clinical "test set" in the context of an AI/ML algorithm evaluation. No specific sample sizes for clinical data, country of origin, or retrospective/prospective nature are mentioned because the submission relies on bench testing and material specifications to demonstrate substantial equivalence to the predicate device, which is a common approach for device modifications under 510(k). Clinical data may not be required if the technological characteristics are shown to be substantially equivalent and do not raise new safety or effectiveness concerns.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" established by experts is a concept primarily relevant to the evaluation of diagnostic software, especially AI/ML, where human interpretation is being compared or enhanced. This submission is for a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical device substantial equivalence submission where bench testing against standards is performed.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for a physical device, not an AI/ML diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device like a ureteral stent, the "ground truth" for proving performance typically involves:
- Material specifications and biocompatibility testing: Ensuring the materials used are safe and perform as intended.
- Mechanical and functional testing: Bench testing the device to ensure properties like tensile strength, flexibility, flow rates, and in-vivo behavior (e.g., kink resistance, migratory prevention) meet established standards or are comparable to the predicate.
- Sterilization validation: Ensuring the device is sterile.
- Packaging integrity testing.
The submission states, "Performance and functional testing standards are based on the FDA draft "Guidance for the Content of Premarket Notifications for Ureteral Stents" dated February 10, 1993 and the draft ASTM F.04.70.01, "Standard Test Method for Ureteral Stents" dated July 9, 1997." These standards and guidelines serve as the "ground truth" for evaluating the physical and functional aspects of the stent.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).